Determination of 23 elemental impurities in nedaplatin for injection,nedaplatin and excipients by ICP-MS
10.19778/j.chp.2024.06.009
- VernacularTitle:ICP-MS法测定注射用奈达铂及其原辅料中23种元素杂质的含量
- Author:
Xiaochun HUANG
1
;
Jinfeng HOU
1
;
Qi LIU
1
;
Zhaozhen LIU
1
;
Haitao LIU
1
;
Baoquan CHE
1
Author Information
1. 北京市药品检验研究院,国家药品监督管理局仿制药研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京 102206
- Publication Type:Journal Article
- Keywords:
elemental impurities;
nedaplatin for injection;
ICP-MS;
risk assessment
- From:
Drug Standards of China
2024;25(6):584-589
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish an ICP-MS method for the determination of 23 potential risk elemental im-purities including As,Cd,Hg,Pb,Co,Ni,V,Ag,Au,Ir,Os,Pd,Rh,Ru,Se,Tl,Ba,Cr,Cu,Li,Mo,Sb,Sn in nedaplatin for injection,nedaplatin and excipients.Methods:Inductively coupled plasma mass spec-trometry(ICP-MS)was used to establish a method for the contents of 23 elemental imputities in nedaplatin for in-jection,nedaplatin and excipients,and relevant methodological validation were carried out.The samples were pre-treated by directly dissolution.Results:The method simultaneously determined 23 elemental impurities.The re-sponse values of the 23 elemental impurities showed a good linear relationship with their mass concentrations(r≥0.99).The relative standard deviations(RSDs)of the repeatability tests were less than 9％(n=6),and the av-erage recovery rates ranged from 94％to 116％(n=9),which all met the requirements of methodological valida-tion.The contents of 23 elemental impurities in total 16 batches from 4 manufacturers of nedaplatin for injection were all below 30％of the limits specified by ICH Q3D.Conclusion:The established ICP-MS method is simple,sensitive,accurate,and has good specificity and repeatability.It can be used as a quality control detection method for 23 elemental impurities in the platinum based anti-tumor drug substances and products.
